E-cigarette use, driven primarily by Juul, by youth continues to accelerate (see figure provided by Tom Eissenberg), as does multi-product use, led by dual use of e-cigarettes and cigarettes. In addition to the rapid growth in e-cig use, the historic decline in cigarette smoking has stopped. This is exactly what one would expect if e-cigarettes were bringing new low-risk kids into the market and acting as a gateway for cigarette smoking.

Of course, even if the kids did not go on to smoke cigarettes, addicting a new generation of kids to nicotine e-cigs is a bad thing.

The exploding use of e-cigs led FDA Commissioner Scott Gottlieb to say, “The epidemic use of e-cigarettes among children is one of the biggest public health challenges currently facing the FDA.”

Here are some excerpts from his public statement:

According to the data released today, approximately 4.9 million middle and high school students were current users (used in the past 30 days) of some type of tobacco product in 2018, up from 3.6 million in 2017. This increase is driven by an alarming surge in e-cigarette use. More than 3.6 million middle and high school students were current (past 30 day) e-cigarette users in 2018, a dramatic increase of more than 1.5 million students in one year. The study authors suggest -- as the FDA also noted at the time of the initial release of this data in the fall – that the rise in e-cigarette use in the last year is likely due to the recent popularity of certain types of e-cigarettes, such as JUUL. Further, youth who use e-cigarettes also are using them more frequently and using flavored products more often than last year. Many youth tobacco product users are also using multiple products.

…

Based on a growing body of evidence, I fear the youth trends will continue in 2019, forcing us to make some tough decisions about the regulatory status of e-cigarettes. The signs that we’re seeing are not encouraging.

Evidence shows that minors are especially attracted to flavored e-cigarette products, and that youth access these products from both brick and mortar retailers as well as online. With that in mind, we’re revisiting our compliance policy that has resulted in certain e-cigarettes, including flavored e-cigarettes, remaining on the market until 2022 while their manufacturers submit applications for premarket authorization. In particular, as I announced on Nov. 15, 2018, the FDA is revisiting the compliance policy on premarket tobacco product application authorization for all flavored e-cigarette products other than tobacco, mint, and menthol, sold in physical locations where people under the age of 18 are permitted. For example, this would include e-cigarettes or electronic nicotine delivery system (ENDS) products, such as e-liquids, cartridge-based systems, and cigalikes, in fruit and candy flavors like cherry, vanilla, crème, tropical, melon and others. In addition, we will seek to curtail the sale of applicable flavored ENDS products that are sold online without heightened age verification processes.

…

The agency is also exploring action under both its civil and criminal enforcement tools to target potentially violative sales and marketing practices by manufacturers as well as retailers. … [and] plan to meet with state attorneys general to discuss how they can help combat youth e-cigarette use in their states.

While this is all fine, the fact is that there are things that the FDA could do right now.As we noted in a recent public comment to FDA, every every e-cig on the market, including Juul (and similar products all the other companies are now selling), became illegal in 2016 when the FDA issued its deeming rule.

The only reason e-cigarettes can still be sold is because FDA is exercising “enforcement discretion” and not enforcing the law to give the e-cig companies time to provide the materials FDA has to evaluate to determine whether the products should be sold.

FDA could and should take all e-cigs, including Juul, off the market today (except, perhaps, tobacco flavor) by simply stopping to exercise enforcement discretion. Doing so would not require any rulemaking, which takes years.

Commissioner Gottlieb is now talking about this power; he needs to use it. As he noted, the number of students using e-cigarettes increased by 1.5 last year. As the graph above indicates, this process is accelerating, so, absent meaningful action, this number is likely to be even bigger next year. The time to act is now.

In addition, Commissioner Gottlieb should stop making favorable statements about e-cigs that would be illegal if a manufacturer made them (e-cigs are less dangerous than cigarette [a modified risk claim] and that they help adults quit [a therapeutic claim]). The CDC also included a similar statement in the MMWR, citing the 2014 Surgeon General’s report (at the beginning of the second paragraph of their paper.) 2014 is a lifetime ago in terms of our understanding of the adverse health effects of e-cigarettes and CDC should not be relying on such an old document.

In the meantime, localities and states need to continue to step into the vacuum by passing local laws ending the sale of all flavored tobacco products, as San Francisco did. The CDC and Surgeon General are recommending such action.

Commissioner Gottlieb should also heed the CDC advice to "[r]eject tobacco industry-sponsored prevention programs, which are proven not to work."

But, the FDA could solve the problem with the stroke of a pen by ending its enforcement discretion now.

Comments

Do things need to get worse before FDA takes serious action? Three times in his statement, Commissioner Gottlieb repeated what he has said before: that if the current upward trends in youth e-cig use continue FDA would be forced to consider taking stricter steps against e-cigs (even if that makes them less readily available to adults). [For example: "If these youth trends continue, we’ll be forced to consider regulatory steps . . .”] Do these quotes mean FDA will not issue any new rules or modify the free ride it is giving e-cigs on the market until 2022+ if youth e-cig use stabilizes at the currently high levels that FDA-calls a crisis?

Meanwhile, all FDA has done is some increased enforcement, its ad campaign, and trying to get the industry to take voluntary action. At the same time, FDA is currently failing to enforce the TCA requirement that new or substantially changed e-cigs must get a permissive PMTA order before entering the U.S. market. From what I understand, Juul, NJOY, and others have new/changed brands that are on the market without a PMTA and did not enter the market until after deeming went into effect (the deadline for being subject to FDA’s 2020 enforcement discretion).

On the other hand, Gottlieb said that “FDA has a number of actions planned and we’ll have more to say on these and other actions soon.”

My guess is that OMB or the White House has told Gottlieb that they won’t let him do anything big unless the problem gets a lot worse and there is a big outcry about it.

Perhaps some reporter needs to ask Trump on camera what his Administration is going to do to stop the explosion of new youth becoming addicted to e-cigarettes.

Eric N. Lindblom, JD
Director, Tobacco Control and Food & Drug Law
O'Neill Institute for National and Global Health Law
Georgetown University Law Center
Washington, DC 20001[email protected]www.oneillinstitute.org